--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Effects of other drugs" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Effects of other drugs. Topics: Drug interaction studies and nucleos(t)ide analogue coadministration: prescribing information, Bepirovirsen exposure with and without entecavir or tenofovir: phase 2a study, No effect of nucleos(t)ide analogues on bepirovirsen pharmacokinetics, Nucleos(t)ide analogue treatment status as a covariate in the population pharmacokinetic model, and 1 further topic. 5 evidence topics quoted from 3 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description/effects-of-other-drugs" published: "2026-10-21T22:39:04-04:00" modified: "2026-10-22T19:07:03-04:00" --- # Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Effects of other drugs ## 2.1.2.9.1 Effects of Other Drugs on Bepirovirsen ### Drug interaction studies and nucleos(t)ide analogue coadministration: prescribing information > “No formal clinical drug interaction studies have been conducted with HIBSAGO. In clinical trials, concomitant administration of HIBSAGO with a NrtI did not result in changes in bepirovirsen exposure.” > “Based on in vitro study results, HIBSAGO is not a substrate, inducer or inhibitor of major cytochrome P450 (CYP) enzymes, or drug transporters; therefore, clinically relevant pharmacokinetic interactions are not expected.” Source: [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF) ### Bepirovirsen exposure with and without entecavir or tenofovir: phase 2a study | Group and study day | AUC0-24 (µg•h/mL), mean (SD) | AUCtau (µg•h/mL), mean (SD) | Cmax (µg/mL), mean (SD) | tmax (hour), mean (SD) | | --- | --- | --- | --- | --- | | Bepirovirsen 300 mg, day 1 (n = 12) | “134 (44.2)” | Not applicable | “10.6 (3.4)” | “4.0 (1.3)” | | Bepirovirsen 300 mg, day 22 (n = 12) | “117 (34.9)” | “146 (34.7)” | “9.5 (3.1)” | “3.4 (0.9)” | | Bepirovirsen 300 mg plus entecavir or tenofovir, day 1 (n = 5) | “123 (33.1)” | Not applicable | “9.7 (2.2)” | “4.1 (0.4)” | | Bepirovirsen 300 mg plus entecavir or tenofovir, day 22 (n = 4) | “111 (54.3)” | “147 (38.0)” | “8.8 (4.7)” | “4.2 (1.2)” | Source: [Han et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11975176/) ### No effect of nucleos(t)ide analogues on bepirovirsen pharmacokinetics > “Bepirovirsen plasma pharmacokinetic parameters and concentration–time profiles in patients with chronic HBV in the CS3 study (NCT02981602) were similar with or without ETV or TFV coadministration, indicating no effect of NA coadministration on bepirovirsen pharmacokinetics.” > “Bepirovirsen was not an in vitro substrate of MRP2, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, or MATE2‐K.” > “Although reliable and meaningful efflux ratios could not be determined for P‐gp or BCRP, bepirovirsen is unlikely to be a substrate of P‐gp or BCRP efflux transporters.” > “ASOs are not typically metabolized by CYP enzymes but are instead primarily metabolized by endonucleases and exonucleases or have been chemically modified to resist degradation.” Source: [Han et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11975176/) ### Nucleos(t)ide analogue treatment status as a covariate in the population pharmacokinetic model > “Results of this PK analysis suggest that no dose adjustment should be recommended for bepirovirsen based on demographic or baseline characteristics, or according to nucleos(t)ide analogue treatment status.” Source: [Youssef et al. (2024)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11219612/) ### Limitations of the drug interaction assessment > “Second, only the most common NAs used to treat chronic HBV infection (ETV and TFV) 3 were evaluated as perpetrator and victim in this analysis.” > “Third, the small sample size did not allow for any statistical comparison.” Source: [Han et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11975176/) ## Related pages - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Terms and abbreviations](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations.md) - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Product information and disease description](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Clinical evidence](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: new drug review](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: cost-effectiveness analyses and utility weights](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses.md)